Chapter 11: Integrated Data and Regulatory Submissions
Representing Subjects Who Appear in Multiple Studies in Subject-Level Data Sets
Deciding Which Data to Integrate
Summary of Data Integration Strategies
Data Integration and Submission Tools
Setting Variable Lengths Based on the Longest Observed Value
Converting from Native SAS to Version 5.0 Transport Files
Converting from Version 5.0 Transport Files to Native SAS
The term integration in clinical trial parlance has its roots in the Code of Federal Regulations that outlines the content and format of a new drug application. These regulations state that ...
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